-ADXS-NEO is being evaluated in a Phase 1 clinical trial in various cancers

-First patient dosed is being treated for NSCLC

"We are committed to realizing the potential of ADXS-NEO to mobilize patients’ immune systems against mutations that accumulate within and contribute to the development of their cancer, and to bring the potential benefits of our technology to more patients and their families."

PRINCETON, N.J.--(BUSINESS WIRE)--Advaxis,
Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on
the discovery, development and commercialization of immunotherapy
products, announced it has commenced a Phase 1 trial with the dosing of
the first patient with ADXS-NEO, an investigational personalized
immunotherapy approach targeting personal neoantigens found by
sequencing a patient’s own cancer cells. ADXS-NEO is being evaluated in
an open-label, dose-escalation, multicenter Phase 1 clinical trial in
the United States. The study is open to patients with metastatic
non-small cell lung cancer (NSCLC), metastatic microsatellite stable
colon cancer and metastatic squamous head and neck cancer. The first
patient dosed is being treated for non-small cell lung cancer. ADXS-NEO
is being developed in collaboration with Amgen. Advaxis is leading
clinical development through proof-of-concept.

Pre-clinical findings for ADXS-NEO were presented at the 2018 American
Association for Cancer Research (AACR) Annual Meeting. The company
presented data in mouse models showing that ADXS-NEO generates T cell
responses against neoantigen peptides that control tumor growth, even
when they were identified as “non-immunogenic” using a conventional
peptide-adjuvant immunization. Additionally, data were presented
highlighting the capacity of the Advaxis Lm vector and its
ability to target frameshift mutations of greater than 90 amino acids,
and to generate T cells to multiple neoantigens per frameshift in tumor
mouse models.

“We are extremely pleased to advance ADXS-NEO into the clinic. This
program brings our clinically-validated Lm Technology to the
cutting-edge area of neoantigen immuno-oncology,” said Kenneth A.
Berlin, President and Chief Executive Officer of Advaxis. “We are
committed to realizing the potential of ADXS-NEO to mobilize patients’
immune systems against mutations that accumulate within and contribute
to the development of their cancer, and to bring the potential benefits
of our technology to more patients and their families.”

Enrolled patients will undergo a biopsy, and Advaxis will then
manufacture an investigational personalized treatment for each patient
based on an analysis of their tumor neoantigen mutations, which will be
ready to dose within 8 weeks of the initial biopsy. More information
about the trial is available at www.clinicaltrials.gov.

About ADXS-NEO

ADXS-NEO is an investigational personalized Listeria monocytogenes
(Lm)-based immunotherapy designed to generate immune response
against mutation-derived tumor-specific neoantigens identified through
DNA sequencing of a patient’s own tumors. The program focuses on
creating a customized treatment for each patient targeting multiple
neoantigens found in a biopsy of the patient’s tumor. ADXS-NEO is being
developed in partnership with Amgen.

About Advaxis, Inc.

Advaxis, Inc. is a late-stage biotechnology company focused on the
discovery, development and commercialization of proprietary Lm-based
antigen delivery products. These immunotherapies are based on a platform
technology that utilizes live attenuated Listeria monocytogenes (Lm)
bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based
strains are believed to be a significant advancement in immunotherapy as
they integrate multiple functions into a single immunotherapy and are
designed to access and direct antigen presenting cells to stimulate
anti-tumor T cell immunity, activate the immune system with the
equivalent of multiple adjuvants, and simultaneously reduce tumor
protection in the tumor microenvironment to enable the T cells to
eliminate tumors. Advaxis has product candidates in various stages of
clinical and preclinical development in the following areas:
HPV-associated cancers, neoantigen therapy, hotspot/cancer antigens and
prostate cancer.

Some of the statements included in this press release may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the safe
harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995. The factors that could cause
our actual results to differ materially include: our ability to develop
and commercialize the next generation of cancer immunotherapies; the
safety and efficacy of our proprietary immunotherapies; the success and
timing of our clinical trials, including patient accrual; our ability to
release the clinical hold and reduce the impact to our trials; our
ability to obtain and maintain regulatory approval and/or reimbursement
of our product candidates for marketing; our plans to develop and
commercialize our products; our ability to successfully compete in the
potential markets for our product candidates, if commercialized; our
ability to obtain additional funding; the success and timing of our
preclinical studies including IND enabling studies; and our ability to
successfully implement our strategy. These forward-looking statements
are subject to a number of risks including the forward-looking
statements and risk factors set forth from time to time in Advaxis’ SEC
filings including, but not limited to, our report on Form 10-K for the
fiscal year ended October 31, 2017, and on Form 10-Q for the quarter
ended January 31, 2018, which are available at www.sec.gov.

Any forward-looking statements set forth in this press release speak
only as of the date of this presentation. We do not intend to update any
of these forward-looking statements to reflect events or circumstances
that occur after the date hereof other than as required by law. You are
cautioned not to place undue reliance on any forward-looking statements.